Perioperative cardiac events frequently complicate non-cardiac surgery resulting in significant morbidity, mortality and cost. There is no clear evidence from RCTs on how to lower perioperative cardiac risk. This a multi-centre, double-blind, randomized controlled group trial of metoprolol vs placebo in 10,000 moderate and high risk patients undergoing non-cardiac surgery.
Conditions
Interventions
Trade Name: Betaloc IV INJ 1 MG/ML
Product Name: Betaloc IV INJ 1 MG/ML
Product Code: 00719846
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Tablet
Route of administration of the
Sponsors
Canadian Cardiovascular Collaboration, Population Health Research Institute, McMaster University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible if they are undergoing non cardiac surgery; age > 45 years, have an expected length of hospital stay > 24 hours for surgical reasons, AND fulfill any one of the following six criteria: history of coronary artery disease, peripheral vascular disease, history of stroke thought due to atherothrombotic disease, hospitalization for congestive heart failure within 3 years of randomization, undergoing major vascular surgery OR fulfill any 3 of the following 7 risk factors: undergoing high-risk type surgery (intrathoracic, intraperitoneal), any history of congestive heart failure, diabetes and currently on an oral hypoglycemic agent or insulin therapy, pre-operative serum creatinine > 175 µmol/L (>2.0 mg/dl), age > 70 years, history of transient ischemic attack, undergoing emergency/urgent surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindication to metoprolol including any of the following: significant bradycardia (heart rate 12% and of at least 200 ml, 15 minutes after inhalation of a beta 2 – agonist). Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days Prior adverse reaction to a beta-blocker CABG surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the CABG surgery Patients undergoing low risk surgical procedures (e.g. transurethral procedures [transurethral prostatectomies (TURPs), stone baskets, etc], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc] ) Concurrent use of verapamil; OR Prior enrollment in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the impact of perioperative administration of metoprolol on cardiovascular events during the 30 day post-operative period in moderate and high-risk patients undergoing non-cardiac surgery. ;Secondary Objective: Secondary objectives include an evaluation of the impact of metoprolol on long-term risk of cardiovascular events and the effect of perioperative metoprolol on length of hospital stay/ICU/CCU.;Primary end point(s): There will be adjudication of the primary outcomes (i.e. cardiovascular death, nonfatal myocardial infarction, and nonfatal cardiac arrest) by a blinded adjudication committee. Clinical centers will therefore forward supporting documents for these outcomes. | — |
Countries
Denmark, Spain
Outcome results
None listed